Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
59497–59520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2007
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
K070561 · HTY
Teleflex Medical
Orthopedic · 87d
Cleared May 25, 2007
DIO PROTEM IMPLANT SYSTEM
K070568 · DZE
Dio Department Dsi, Inc.
Dental · 86d
Cleared May 25, 2007
ACCU-CHEK PERFORMA SYSTEM
K070585 · NBW
Roche Diagnostics Corp.
Chemistry · 85d
Cleared May 25, 2007
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
K070739 · FKT
Renal Solutions, Inc.
Gastroenterology & Urology · 70d
Cleared May 25, 2007
LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR
K070825 · DXN
Little Doctor (Shanghai) Electronic...
Cardiovascular · 60d
Cleared May 25, 2007
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS...
K070887 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 56d
Cleared May 25, 2007
SYSMEX MODEL UF1000I
K070910 · LKM
Sysmex America, Inc.
Pathology · 53d
Cleared May 25, 2007
MONARCH NASAL IMPLANT
K071018 · FZE
Hanson Medical, Inc.
General & Plastic Surgery · 45d
Cleared May 25, 2007
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
K071075 · DXN
Terumo Corp.
Cardiovascular · 39d
Cleared May 25, 2007
PALOMAR ERBIUM HANDPIECE
K071152 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 30d
Cleared May 25, 2007
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
K071173 · HAX
Ossur Americans (Formerly the Jerome...
Neurology · 28d
Cleared May 25, 2007
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT...
K071215 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d
Cleared May 25, 2007
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT...
K071216 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d
Cleared May 25, 2007
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · MEB
Baxter Healthcare Corp
General Hospital · 23d
Cleared May 25, 2007
VITREA VERSION 4.0
K071331 · LLZ
Vital Images, Inc.
Radiology · 14d
Cleared May 24, 2007
OSTIAL PRO STENT POSITIONING SYSTEM
K062192 · DQX
Ostial Solutions, LLC
Cardiovascular · 297d
Cleared May 24, 2007
RHYTHM TOUCH Q 2-WAY
K063743 · NUH
Shockim Enterprises, Ltd.
Neurology · 157d
Cleared May 24, 2007
WELMED, INC. SURGICAL GOWNS
K070431 · FYA
Welmed, Inc.
General Hospital · 100d
Cleared May 24, 2007
MICRUS COURIER ENZO MICROCATHETER 0.017
K070456 · DQO
Micrus Endovascular Corporation
Cardiovascular · 97d
Cleared May 24, 2007
SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR
K070595 · FRC
Spsmedical Supply Corp.
General Hospital · 83d
Cleared May 24, 2007
IMM HYPODERMIC NEEDLE SET
K070801 · FPA
Innovative Medical Manufacturing Co.
General Hospital · 62d
Cleared May 24, 2007
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K070905 · DZE
Southern Implants, Inc.
Dental · 52d
Cleared May 24, 2007
MODEL PMT850
K070931 · ILX
Promedtek, Inc.
Physical Medicine · 51d
Cleared May 24, 2007
LIGHT RELIEF, MODEL LR150, LR200
K070974 · ILY
Light Relief, LLC
Physical Medicine · 48d